Monthly medicines update
Summary of new marketing authorisations and changes to existing authorisations that relate to the safe use of the product
A rolling 6 month summary with the most recent one first.
Our Product Information Database (PID) is your primary resource for the most current information about all veterinary medicines authorised in Great Britain and Northern Ireland. As product details change we update the Summary of Product Characteristics (SPC) and label text there. Please note there may be a delay before formal documentation is available for some Northern Ireland products.
It may take up to 12 months for changes to appear on marketed packaging.
Products are authorised separately in Great Britain and Northern Ireland although authorisations may be aligned if they are the same product held by the same authorisation holder. This may mean that products are authorised or changed on different timescales in each territory.
Also find here a list of specific Pregnancy Warnings which we update quarterly.
March 2026
Change of distribution category
The following product has a change of distribution category to POM-VPS
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Flukanide 30 mg/ml Oral Suspension for Sheep
Active substance: Rafoxanide
Territory / Distribution category: UK POM-VPS
Authorisation holder: Univet Limited
Change category: Distribution Category
Summary of change: Change of distribution (legal) category to POM-VPS.
New Authorisations
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AquaVac S7 Emulsion for Injection for Atlantic Salmon
Active substance: Infectious pancreatic necrosis virus, Aeromonas salmonicida subsp. salmonicida, Vibrio salmonicida, Listonella anguillarum, Listonella anguillarum, Moritella viscosa, Yersinia ruckeri
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Intervet International B.V.
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Buproxan Multidose 0.3 mg/ml Solution for Injection for Dogs, Cats and Horses
Active substance: Buprenorphine
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Alfasan Nederland B.V.
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Ketiva 150 mg/ml Solution for Injection for Cattle, Pigs and Horses
Active substance: Ketoprofen
Territory / Distribution category: GB & NI POM-V
Authorisation holder: VetViva Richter GmbH
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Nexpraz Duo 18.7 mg/g + 140.3 mg/g Oral Paste for Horses
Active substance: Ivermectin, Praziquantel
Territory / Distribution category: NI POM-VPS
Authorisation holder: Bioveta, a.s.
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Rokopig Entero Emulsion for Injection (Pigs)
Active substance: Escherichia coli, Clostridium perfringens, Porcine rotavirus
Territory / Distribution category: GB POM-V
Authorisation holder: Bioveta, a.s.
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Buprecord 0.3 mg/ml Solution for Injection for Dogs and Cats
Active substance: Buprenorphine
Territory / Distribution category: GB POM-V
Authorisation holder: Labiana Life Sciences SA
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Maropicord 10 mg/ml Solution for Injection for Dogs and Cats
Active substance: Maropitant
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Accord Healthcare B.V
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Robenord 20 mg/ml Solution for Injection for Cats and Dogs
Active substance: Robenacoxib
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Accord Healthcare B.V
Variations - Food producing species
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Altresyn 4 mg/ml Oral Solution for Pigs
Active substance: Altrenogest
Territory / Distribution category: NI POM-V
Authorisation holder: Ceva Sante Animale
Change Category: Target Species Use
Summary of change:
SPC section 3.1: Change of target species to ‘Pigs (sexually mature gilts and weaned sows)’. Therefore, the product may now be used in multiparous sows.
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Avipro Thymovac Lyophilisate for Use in Drinking Water (Chickens)
Active substance: Chicken anaemia virus strain Cux-1
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
Change Category: Target Species Use
Summary of change:
SPC section 3.2: Addition of future layers as target species subcategory and to add the protection against viraemia to the indication.
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Cocci-Drench 2.5 mg/ml Oral Suspension (Cattle, Sheep)
Active substance: Diclazuril
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Intervet International B.V.
Change Category: Adverse Reactions
Summary of change:
SPC section 3.6: Addition of the following adverse events in sheep (lambs) and cattle (calves), all with very rare frequency (i.e. <1 animal / 10,000 animals treated, including isolated reports): Gastrointestinal signs (e.g. Diarrhoea (1),(2)); Lethargy, Recumbency; Agitation; Neurological signs (e.g. Paresis).
(1) with possible presence of blood.
(2) in some treated animals, even though oocyst excretion is reduced to a very low level.
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Molecoxan 2.5 mg/ml Oral Suspension (Cattle, Sheep); Vecoxan 2.5 mg/ml Oral Suspension (Cattle, Sheep)
Active substance: Diclazuril
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Intervet International B.V.
Change Cateogry: Adverse Reactions
Summary of change:
SPC section 3.6: Addition of the following adverse events in sheep (lambs) and cattle (calves), all with very rare frequency (i.e. <1 animal / 10,000 animals treated, including isolated reports): Gastrointestinal signs (e.g. Diarrhoea (1),(2)); Lethargy, Recumbency; Agitation; Neurological signs (e.g. Paresis).
(1) with possible presence of blood.
(2) in some treated animals, even though oocyst excretion is reduced to a very low level.
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Enroxil 100 mg/ml Oral Solution for Chickens and Turkeys
Active substance: Enrofloxacin
Territory / Distribution category: UK POM-V
Authorisation holder: KRKA, d.d., Novo mesto
Change Category: Target Species Use
Summary of change:
SPC section 6.2: Addition of the following warning concerning incompatibilities: ‘In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products. No information is available on potential incompatibilities of this veterinary medicinal product administered orally by mixing into drinking water containing biocidal products, feed additives or other substances used in drinking water.’
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Epricert 5 mg/ml Pour-on Solution for Beef and Dairy Cattle, Sheep and Goats
Active substance: Eprinomectin
Territory / Distribution category: NI POM-V
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Change Category: Target Species Use
Summary of change:
SPC section 3.1: Addition of sheep and goats as new target species, with the following indications:
Sheep:
Gastrointestinal roundworms (adults)
Teladorsagia circumcincta (pinnata/trifurcata)
Haemonchus contortus
Trichostrongylus axei
Trichostrongylus colubriformis
Nematodirus battus
Cooperia curticei
Chabertia ovina
Oesophagostomum venulosum
Lungworm (adult)
Dictyocaulus filaria
Nasal Bots (L1, L2, L3)
Oestrus ovis
Goats:
Gastrointestinal roundworms (adult)
Teladorsagia circumcincta (pinnata/trifurcata)
Haemonchus contortus
Trichostrongylus axei
Trichostrongylus colubriformis
Nematodirus battus
Cooperia curticei
Oesophagostomum venulosum
Lungworm (adult)
Dictyocaulus filaria
Nasal Bots (L1, L2, L3)
Oestrus ovis
Warbles (L1, L2, L3)
Przhevalskiana silenus
The product name has been changed to ‘Epricert 5 mg/ml Pour-on Solution for beef and dairy cattle, sheep and goats’
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Noroclav Injection for Cattle and Dogs (Cattle, Dogs, Cats)
Active substance: Amoxicillin, Clavulanic Acid
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Norbrook Laboratories Limited
Change Category: Target Species Use
Summary of change:
SPC section 3.1: Addition of cats as a target species. The product is indicated in cats for treatment of respiratory tract infections, urinary tract infections, and skin and soft tissue infections (e.g. abscesses, pyoderma, anal sacculitis and gingivitis). The product name has been changed to Noroclav Injection for Cattle, Dogs and Cats.
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Pergocoat 0.5 mg / 1 mg / 2 mg Film-coated Tablets for Horses
Active substance: Pergolide
Territory / Distribution category: NI POM-V
Authorisation holder: Alfasan Nederland B.V.
Change Category: Contraindications, Special Warnings
Summary of change:
SPC section 3.5: ‘Pergolide, like other ergot derivatives, may cause emesis, dizziness, lethargy or low blood pressure. Severe adverse events such as collapse have been observed. Ingestion may be harmful and associated with severe adverse events, especially in children or people with pre-existing heart conditions. Take utmost care to avoid accidental ingestion of the veterinary medicinal product.’ Refer to section 3.5 of the SPC for further advice on reducing the risk of accidental ingestion.
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Suvaxyn PRRS MLV Lyophilisate and Solvent for Suspension for Injection for Pigs
Active substance: Porcine respiratory and reproductive syndrome virus
Territory / Distribution category: NI POM-V
Authorisation holder: Zoetis Belgium
Change Category: Adverse Reactions, Interactions & Overdose
Summary of change:
SPC sections 3.6 and 3.8: Addition of the option of using a needle-free device for intramuscular injections.
SPC available from EU Union Product Database
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Uniferon 20% Solution for Injection (Pigs)
Active substance: Iron
Territory / Distribution category: UK POM-VPS
Authorisation holder: Pharmacosmos A/S
Change Category: Withdrawal Period; Adverse Reactions; Interactions and Overdose
Summary of change:
SPC section 3.12: Change in withdrawal period for meat and offal from 28 days to zero days.
SPC section 3.6: Addition of hypersensitivity reactions and transient injection site skin discolouration/calcification as very rare adverse events (<1 animal / 10,000 animals treated, including isolated reports).
SPC section 3.10: Addition of the following symptoms of overdose:
• Transferrin-iron saturation levels leading to increased susceptibility for (systemic) bacterial disease, pain, inflammation reactions as well as abscess formation at the injection site may occur;
• Persistent discoloration of muscle tissue at the injection site may occur;
• Iatrogenic poisoning with the following symptoms: pale mucous membranes, hemorrhagic gastroenteritis, vomiting, tachycardia, hypotension, dyspnoea, edema of the limbs, lameness, shock, death, liver damage. Supportive measures such as chelating agents can be used
Variations - Companion animal species
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Bravecto 150 mg/ml Powder and Solvent for Suspension for Injection for Dogs
Active substance: Fluralaner
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change Category: Adverse Reactions
Summary of change:
SPC section 4.6: Additional adverse events: Emesis, diarrhoea (rare, i.e. 1 to 10 animals/10,000 animals treated). Allergic oedema, Hypersensitivity reaction, Pruritus (Very rare, i.e. < 1 animal/10,000 animals treated, including isolated reports).
SPC section 4.5: Additional user safety warnings: ‘If accidental skin exposure occurs, wash the skin immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with clean water.’
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Credelio Chewable Tablets for Dogs (Range); Credelio Plus Chewable Tablets for Dogs (Range)
Active substance Credelio: Lotilaner
Active substance Credelio Plus: Lotilaner & Milbemycin Oxime (A3 and A4)
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
Change Category: Target Species Use
Summary of change:
SPC section 3.2: Additional indications ‘For the treatment of sarcoptic mange (Sarcoptes scabiei var canis)’ and ‘For reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus for one month. The effect is indirect due to the activity of the veterinary medicinal product against the vector.’
Link to SPC Credelio Plus 56.25mg/2.11mg
Link to SPC Credelio Plus 112.5mg/4.22mg
Link to SPC Credelio Plus 225mg/8.44mg
Link to SPC Credelio Plus 450mg/16.88mg
Link to SPC Credelio Plus 900mg/33.75mg
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Daxocox Tablets for Dogs (Range)
Active substance: Enflicoxib
Territory / Distribution category: GB POM-V
Authorisation holder: Ecuphar NV
Change Category: Target Species Use
Summary of change:
SPC section 3.2: Addition of the indication ‘For the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery' and section 3.9 associated dosing information for perioperative use.
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Nobivac KC Nasal Drops, Lyophilisate and Solvent for Suspension for Dogs
Active substance: Bordetella bronchiseptica,
Canine parainfluenza virus
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International B.V.
Change Category: Contraindications, Special Warnings
Summary of change:
SPC section 3.5: Addition of Special precautions 'Avoid accidental self-injection or contact with the eyes. In case of ocular irritation or accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.'
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YURVAC RHD Emulsion for Injection for Rabbits
Active substance: Recombinant RHDV2 virus capsid protein
Territory / Distribution category: GB POM-V
Authorisation holder: Laboratorios Hipra SA
Change Category: Adverse reactions
Summary of change:
Section 3.6: Addition of adverse events; lethargy, and lameness at a frequency of very rare (<1animal/10,000 treated, including isolated reports).
SPC available from the EU Union Product Database
February 2026
New Authorisations
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Biosuis ParvoEry Suspension for Injection for Pigs
Active substance: Porcine parvovirus, Erysipelothrix rhusiopathiae
Territory / Distribution category: GB POM-V
Authorisation holder: Bioveta, a.s.
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Carprofen Norbrook 50 mg/ml Solution for Injection for Cattle
Active substance: Carprofen
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Norbrook Laboratories Limited
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Intra Dysovinol 499 mg/ml Solution for Use in Drinking Water for Pigs
Active substance: Zinc disodium EDTA, aqueous solution 39%
Territory / Distribution category: GB POM-V
Authorisation holder: Intracare BV
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Mastavance 20 mg Intramammary Suspension
Active substance: Hydrocortisone aceponate
Territory / Distribution category: GB POM-V
Authorisation holder: VIRBAC
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Vimectanin DUO 50 mg/ml + 1 mg/ml Oral Suspension for Sheep
Active substance: Triclabendazole, Ivermectin
Territory / Distribution category: GB POM-VPS
Authorisation holder: Pharma VIM Kft.
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Iniram 10 mg/ml Solution for Injection for Dogs and Cats
Active substance: Maropitant
Territory / Distribution category: NI POM-V
Authorisation holder: Vet-Agro Multi-Trade Company Sp. z o.o.
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Numelvi 4.8 mg / 7.2 mg / 21.6 mg / 31.6 mg Tablets for Dogs
Active substance: Atinvicitinib
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
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Prevestrus Vet 25 mg / 50 mg / 100 mg Film-coated Tablets for Dogs
Active substance: Finrozole
Territory / Distribution category: GB POM-V
Authorisation holder: Vetcare Oy
Variations - Food producing species
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Dicla-cocci 2.5 mg/ml Oral Suspension for Cattle and Sheep
Active substance: Diclazuril
Territory / Distribution category: NI POM-VPS
Authorisation holder: Huvepharma NV
Change Category: Environmental
Summary of change:
Section 4: Addition of environmental properties: diclazuril has been shown to be very persistent in soil.
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Emdofluxin 50 mg/mL, Solution for Injection for Cattle, Pigs and Horses
Active substance: Flunixin
Territory / Distribution category: GB POM-V
Authorisation holder: Emdoka
Summary of change:
Multiple sections of the SPC have been significantly revised including 3.2 Indications, 3.3 Contraindications, 3.5 Special precautions for use, 3.6 Adverse events, 3.7 Use during pregnancy, lactation, or lay, 3.8 Interactions, 3.9 Administration routes and dosage, 3.10 Overdosage, and 3.12 Withdrawal periods.
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Florgane 300 mg/ml Suspension for Injection for Cattle and Pigs
Active substance: Florfenicol
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Emdoka bvba
Change Category: Target Species Use
Summary of change:
Section 3.2: Indication for use in cattle updated from ‘preventative’ to 'metaphylactic': The presence of the disease in the herd should be established before metaphylactic treatment.
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Flunixin 50 mg/ml Solution for Injection for Cattle, Horses and Pigs
Active substance: Flunixin
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Norbrook Laboratories Limited
Summary of change:
Multiple sections of the SPC have been significantly revised including 3.2 Indications, 3.3 Contraindications, 3.5 Special precautions for use, 3.6 Adverse events, 3.7 Use during pregnancy, lactation, or lay, 3.8 Interactions, 3.9 Administration routes and dosage, 3.10 Overdosage, and 3.12 Withdrawal periods.
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Hipnoton 10 mg/ml Solution for Injection for Horses and Cattle
Active substance: Detomidine Hydrochloride
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Vetpharma Animal Health, S.L
Change Category: Target species use, adverse reactions
Summary of change:
Multiple sections of the SPC have been revised including Section 3.6: Additional adverse events in cattle of penile prolapse (transient) at a frequency of very common, uterine contraction, nasal discharge, hyperthermia, and hypothermia at a frequency of common, arrhythmia at a frequency of rare, and heart block at a frequency of very rare.
Additional adverse events in horses of uterine contraction, hyperthermia, and hypothermia at a frequency of very common, hypersalivation, nasal discharge and skin swelling at a frequency of common, and hypersensitivity reaction at a frequency of very rare.
Section 3.9: Addition of dosage instructions for combinations with other active substances.
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Norfenicol 300 mg/ml Solution for Injection for Cattle and Pigs
Active substance: Florfenicol
Territory / Distribution category: NI POM-V
Authorisation holder: Norbrook Laboratories Limited
Change Category: Contraindications, Special warnings, Adverse reactions
Summary of change:
Section 4.5: Other precautions updated with risks for plants and water organisms.
Section 6.6: Special precautions for the disposal of the product updated: The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.
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Somnipron 10 mg/ml Solution for Injection for Horses and Cattle
Active substance: Detomidine Hydrochloride
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Vetpharma Animal Health, S.L
Change Category: Adverse reactions, Target species use
Summary of change:
Multiple sections of the SPC have been revised including Section 3.6: Additional adverse events in cattle of penile prolapse (transient) at a frequency of very common, uterine contraction, nasal dischare, hyperthermia, and hypothermia at a frequency of common, arrhythmia at a frequency of rare, and heart block at a frequency of very rare.
Additional adverse events in horses of uterine contraction, hyperthermia, and hypothermia at a frequency of very common, hypersalivation, nasal discharge and skin swelling at a frequency of common, and hypersensitivity reaction at a frequency of very rare.
Section 3.9: Addition of dosage instructions for combinations with other active substances.
Variations - Companion animal species
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Caninsulin 40 IU/ml Suspension for Injection (Cats, Dogs)
Active substance: Insulin
Territory / Distribution category: UK POM-V
Authorisation holder: Intervet International B.V.
Change Category: Contraindications, Special warnings, Adverse reactions
Summary of change:
Section 3.3: Do not use in cases of hypoglycaemia.
Section 3.6: Addition of adverse event; hypoglycaemia at a frequency of ‘Rare’ (more than 1 but less than 10 animals in 10,000 animals treated).
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Easimax Plus Tablets for Dogs
Active substance: Febantel, Praziquantel, Pyrantel
Territory / Distribution category: NI NFA-VPS
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Change Category: Adverse reactions
Summary of change:
Section 4.6: Addition of adverse events; lethargy, anorexia, and hyperactivity at a frequency of very rare (<1 animal / 10,000 animals treated, including isolated reports).
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Lotimil 12 mg / 48 mg Chewable Tablets for Cats
Active substance: Lotilaner
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco Europe Ltd
Change Category: Adverse reactions
Summary of change:
Section 3.6: Addition of adverse events; anorexia, lethargy, tachypnoea, ataxia, muscle tremor, hyperactivity and pruritus at a frequency of very rare (<1 animal / 10,000 animals treated, including isolated reports).
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Melosus 0.5 mg/ml Oral Suspension for Cats and Guinea Pigs
Active substance: Meloxicam
Territory / Distribution category: GB POM-V
Authorisation holder: CP Pharma Handelsgesellschaft mbH
Change Category: Target Species Use
Summary of change:
Section 4.2: New indication of alleviation of pain and inflammation in acute musculo-skeletal disorders in cats. Corresponding additional dosage instructions in Section 4.9.
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Nexgard Spectra Chewable Tablets for Dogs [Range]
Active substance: Afoxolaner, Milbemycin Oxime (A3 and A4)
Territory / Distribution catgory: GB POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh
Change Category: Target species use
Summary of change:
Section 3.2 Addition of two new indications:
For reduction of the risk of infection with Babesia canis via transmission by Dermacentor reticulatus for 28 days.
For reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for 30 days.
The effects are indirect due to the activity of the veterinary medicinal product against the vector.
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Nobivac Rabies (Cats, Dogs)
Active substance: Rabies virus
Territory / Distribution catgory: UK POM-V
Authorisation holder: Intervet International B.V.
Change Category: Adverse reactions, Interactions & Overdose
Summary of change:
Section 3.6: Addition of adverse events; lethargy, anorexia and hyperthermia at a frequency of very rare (<1animal/ 10,000 animals treated, including isolated reports).
Section 3.8: Addition of a claim for an associated non-mixed use with Nobivac L4
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Propofol-Lipuro Vet 10 mg/ml Emulsion for Injection (Cats, Dogs)
Active substance: Propofol
Territory / Distribution category: UK POM-V
Authorisation holder: B. Braun Melsungen AG
Change Category: Adverse reactions
Summary of change:
Section 3.6: Addition of adverse events; paddling, myoclonus, opisthotonus at a frequency of common (more than 1 but less than 10 animals in 100 animals treated).
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Quantilex Plus XL Tablets for Dogs
Active substance: Febantel, Praziquantel
Pyrantel Embonate
Territory / Distribution category: NI NFA-VPS
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Change Category: Adverse reactions
Summary of change:
Section 3.6: Addition of adverse events; lethargy, anorexia, and hyperactivity at a frequency of very rare (<1 animal / 10,000 animals treated, including isolated reports).
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YURVAC RHD Emulsion for Injection for Rabbits
Active substance: Recombinant RHDV2 virus capsid protein
Territory / Distribution category: GB POM-V
Authorisation holder: Laboratorios Hipra SA
Change Category: Adverse reactions
Summary of change:
Section 3.6: Addition of adverse events; lethargy, and lameness at a frequency of very rare (<1animal/10,000 treated, including isolated reports).
January 2026
New Authorisations
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Cubarmix Equi 400 mg/g + 80 mg/g Oral Powder for Horses
Active substance: Sulfadiazine, Trimethoprim
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Dopharma Research B.V.
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Lenzelta Suspension for Injection for Cattle
Active substance: Escherichia coli, Staphylococcus aureus
Territory / Distribution category: GB POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica GmbH
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Nobilis Multriva RT+IBm+ND+Gm+REOm+EDS Emulsion for Injection for Chickens
Active substance: Avian metapneumovirus, Infectious bronchitis virus, Newcastle disease virus, Infectious bursal disease virus, Avian reovirus, Egg drop syndrome virus
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
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Pereprin 5 mg/ml Pour-on Solution for Cattle, Sheep and Goats
Active substance: Eprinomectin
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Huvepharma NV
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Roboxera 6 mg Chewable Tablets for Cats
Active substance: Robenacoxib
Territory / Distribution category: NI POM-V
Authorisation holder: KRKA, d.d., Novo mesto
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Thiamavance 10 mg/ml Oral Solution for Cats
Active substance: Thiamazole
Territory / Distribution category: GB & NI POM-V
Authorisation holder: VIRBAC
Variations - Food producing species
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AviPro Salmonella Duo Lyophilisate for Use in Drinking Water (Chickens, Duck, Turkeys)
Active substance: Salmonella enteritidis,
Salmonella typhimurium
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Elanco GmbH
Change Category: Adverse reactions
Summary of change:
Section 3.6 (and other relevant sections): Updated to include the possibility of administration of an additional (forth) dose of vaccine to chickens during lay in around the 50th week of life.
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Eraquell 18.7 mg/g Oral Paste (Horses)
Active substance: Ivermectin
Territory / Distribution category: GB POM-VPS
Authorisation holder: Virbac
Change Category:
Summary of change:
Section 4.9: Before the first administration, the syringe must be primed. Place the ring on the first graduation mark and remove the first jet of paste by pressing the plunger. The syringe is then ready for use.
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Equimax Oral Gel for Horses
Active substance: Ivermectin, Praziquantel
Territory / Distribution category: GB POM-VPS
Authorisation holder: Virbac
Change Category:
Summary of change:
Section 4.9: Before the first administration, the syringe must be primed. Place the ring on the first graduation mark and remove the first jet of paste by pressing the plunger. The syringe is then ready for use.
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Florgane 300 mg/ml Suspension for Injection for Cattle and Pigs
Active substance: Florfenicol
Territory / Distribution category: NI POM-V
Authorisation holder: Emdoka bvba
Change Category: Contraindications; special precautions
Summary of change:
Section 3.5: The use of this veterinary medicinal product may pose a risk for terrestrial plants, cyanobacteria and groundwater organisms.
Section 5.5: The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.
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Flukiver 5% w/v Oral Suspension (Sheep)
Active substance: Closantel
Territory / Distribution category: GB & NI POM-VPS
Authorisation holder: Elanco GmbH
Change Category: Withdrawal period
Summary of change:
Section 3.12: The withdrawal period for meat and offal changed to 56 days.
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Unistrain PRRS Lyophilisate and Solvent for Suspension for Injection for Pigs
Active substance: Porcine respiratory and reproductive syndrome virus
Territory / Distribution category: GB POM-V
Authorisation holder: Laboratorios Hipra SA
Change Category: Target species use
Summary of change:
Section 4.2: Reduction of minimum age of piglets for vaccination to 3 weeks.
Variations - Companion animal species
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Bravecto TriUNO Chewable Tablets for Dogs (Range)
Active substance: Fluralaner, Moxidectin,
Pyrantel
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change Category: Target Species use
Summary of change:
Section 3.2: Addition of a new indication: Treatment of infections with Angiostrongylus vasorum (the causative agent of angiostrongylosis).
Associated changes with this new indication have been made to Section 3.9 (Administration routes and dosage) and additional wording in Section 4.2 (Pharmacodynamics) under Moxidectin.
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Dexdomitor 0.1 / 0.5 mg/ml Solution for Injection (Cats, Dogs)
Active substance: Dexmedetomidine Hydrochloride
Territory / Distribution category: NI POM-V
Authorisation holder: Orion Corporation
Change Category: Target species use
Summary of change:
Section 3.2: Addition of a new indication: To be administered intravenously as a constant rate infusion (CRI) in dogs and cats as part of a multimodal protocol during inhalation anaesthesia.
SPCs available from EU Union Product Database
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Felisecto Plus Spot-on Solution for Cats (Range)
Active substance: Sarolaner Selamectin
Territory / Distribution category: GB POM-V
Authorisation holder: Zoetis UK Limited
Change Category: Target species use; Contraindications, Special warnings
Summary of change:
Section 4.2: Addition of two new indications:
1). For reduction of the risk of Dipylidium caninum via transmission by Ctenocephalides felis for one month after treatment. The effect is indirect due to the product’s activity against the vector.
2). Treatment of notoedric mange (Notoedres cati). Associated information regarding treatment of notoedric mange has been included in Section 4.4 (Special warnings for each target species) and Section 4.9 (Amount(s) to be administered and administration route).
Section 5.1: Selamectin is active against adult fleas (Ctenocephalides spp.) as well as mites (Otodectes cynotis, Notoedres cati), lice (Felicola subrostratus) and gastrointestinal nematodes (Toxocara cati, Ancylostoma tubaeforme). Activity has also been demonstrated against heartworm (D. immitis) larvae.
Selamectin and sarolaner reduces the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis by killing the fleas before disease transmission occurs.
-
Librela Solution for Injection for Dogs (Range)
Active substance: Bedinvetmab
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Zoetis UK Limited
Change Category: Adverse events; Contraindications, Special warnings
Summary of change:
NI
Section 3.6: Adverse events updated: Addition of ataxia, urinary incontinence, anorexia, lethargy at the frequency of “rare” (1 to 10 animals in 10,000 animals treated).
GB
Section 4.5: Caution should be used when treating patients with the following pre-existing conditions: immune-mediated haemolytic anaemia, immune-mediated polyarthritis, immune-mediated thrombocytopenia.
Caution should be used when treating patients with pre-existing seizure disorder.
NI SPCs available from EU Union Product Database
-
Profender Modified release Tablets for Small, Medium and Large Dogs
Active substance: Emodepside Praziquantel
Territory / Distribution catgory: GB POM-V
Authorisation holder: Vetoquinol SA
Change Category: Adverse events
Summary of change:
Section 3.6: Adverse events updated: Digestive tract disorders (e.g. hypersalivation, vomiting, diarrhoea), neurological disorders (e.g. tremor, incoordination), convulsion, behavioural disorders (e.g. hyperactivity), anorexia, lethargy, recumbency, hyperthermia, are currently listed at the frequency of “very rare” (<1 animal in 10,000 animals treated).
-
Profender Spot-on Solution for Small, Medium and Large Cats, and Multi-dose Spot-on Solution for Cats
Active substance: Emodepside Praziquantel
Territory / Distribution catgory: GB POM-V
Authorisation holder: Vetoquinol SA
Change Category: Adverse events
Summary of change:
Section 3.6: Adverse events updated: Neurological disorders (ataxia, tremor), hypersalivation, vomiting, diarrhoea, application site alopecia, application site pruritus, application site inflammation, behavioural disorders (hyperactivity, anxiety, vocalisation), anorexia, lethargy, are currently listed at the frequency of “very rare” (<1 animal in 10,000 animals treated).
Link to SPC Multidose for cats
December 2025
New Authorisations
-
Lenzelta Suspension for Injection for Cattle
Active substance: Escherichia coli, Staphylococcus aureus
Territory / Distribution category: NI POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica GmbH
-
Lexylan 180 mg/ml Suspension for Injection for Cattle, Dogs and Cats
Active substance: Cefalexin
Territory / Distribution category: GB POM-V
Authorisation holder: Emdoka bvba
-
Pergocoat 0.25 mg Film-Coated Tablets for Horses
Active substance: Pergolide mesylate
Territory / Distribution category: NI POM-V
Authorisation holder: Alfasan Nederland B.V.
-
Carpcoat 8 mg /20 mg / 40 mg / 80 mg Film-coated Tablets for Dogs
Active substance: Carprofen
Territory / Distribution category: NI POM-V
Authorisation holder: Alfasan Nederland B.V.
-
Cartaxx 20 mg / 50 mg / 100 mg Chewable Tablets for Dogs
Active substance: Carprofen
Territory / Distribution category: NI POM-V
Authorisation holder: Alfasan Nederland B.V.
-
Chanoxidyl 2 mg/ml Solution for Injection for Cats
Active substance: Meloxicam
Territory / Distribution category: GB & NI POM-V
Authorisation holder: C&H Generics Ltd
-
Dexmedocord 0.5 mg/mL Solution for Injection (Cats, Dogs)
Active substance: Dexmedetomidine Hydrochloride
Territory / Distribution category: NI POM-V
Authorisation holder: Accord Healthcare B.V
-
Meloxaid 2 mg/ml Solution for Injection for Cats
Active substance: Meloxicam
Territory / Distribution category: GB & NI POM-V
Authorisation holder: C&H Generics Ltd
-
Preglukord 1 mg Tablets for Dogs and Cats; Preglukord 5 mg Tablets for Dogs and Cats; Preglukord 25 mg Tablets for Dogs
Active substance: Prednisolone
Territory / Distribution category: NI POM-V
Authorisation holder: Accord Healthcare B.V
-
Rheumocam 2 mg/ml Solution for Injection for Cats
Active substance: Meloxicam
Territory / Distribution category: GB POM-V
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
-
Robexera 6 mg Chewable Tablets for Cats
Active substance: Robenacoxib
Territory / Distribution category: GB POM-V
Authorisation holder: KRKA, d.d., Novo mesto
-
Varenzin 25 mg/ml Oral Suspension for Cats
Active substance: Molidustat sodium
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
Variations - Food producing species
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Betamox 150 mg/ml Suspension for Injection (Cats, Cattle, Dogs, Pigs, Sheep)
Active substance: Amoxicillin
Territory / Distribution category: UK POM-V
Authorisation holder: Norbrook Laboratories Limited
Change Category: Adverse reactions
Summary of change:
Section 4.6: Penicillins and cephalosporins may cause hypersensitivity (allergy, allergic skin reactions) after use. Allergic reactions may occasionally be serious (anaphylaxis).
-
Norfenicol 300 mg/ml Solution for Injection for Cattle and Pigs
Active substance: Florfenicol
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Norbrook Laboratories Limited
Change Category: Environmental impact
Summary of change:
Section 6.6: The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.
Variations - Companion animal species
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Advantage Chewable Tablets for Dogs (Range)
Active substance: Lotilaner
Territory / Distribution category: GB NFA-VPS
Authorisation holder: Elanco GmbH
Change Category: Adverse reactions
Summary of change:
Section 4.6: Additions of bloody diarrhoea, polydipsia, pruritus (itching), inappropriate urination, polyuria (increased urination), and urinary incontinence at a frequency of “very rare” (<1 animal / 10,000 animals treated, including isolated reports).
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Credelio chewable tablets for dogs (Range)
Active substance: Lotilaner
Territory / Distribution category: NI POM-V
Authorisation holder: Elanco GmbH
Change Category: Target species use
Summary of change:
Section 3.2: Addition of two new indications:
For the treatment of sarcoptic mange (Sarcoptes Scabiei).
By killing the vector Dermacentor reticulatus, the veterinary medicinal product reduces the risk of transmission of the vector-borne pathogen Babesia canis canis.
SPCs available from EU Union Product Database
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Credelio Plus Chewable Tablets for Dogs (Range)
Active substance: Lotilaner
Territory / Distribution category: NI POM-V
Authorisation holder: Elanco GmbH
Change Category: Target species use
Summary of change:
Section 3.2: Addition of two new indications:
For the treatment of sarcoptic mange (Sarcoptes Scabiei).
By killing the vector Dermacentor reticulatus, the veterinary medicinal product reduces the risk of transmission of the vector-borne pathogen Babesia canis canis.
SPCs available on the EU Union Product Database
-
Felpreva Spot-on Solution for Cats (Range)
Active substance: Emodepside, Praziquantel,
Tigolaner
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Vetoquinol SA
Change Category: Adverse reactions
Summary of change:
Section 3.6: Addition of Application site reaction (e.g. scratching, erythema, hair loss, inflammation) (mild and transient) at a frequency of “rare” (more than 1 but less than 10 animals in 10,000 animals treated).
NI SPCs available from EU Union Product Database
-
Galastop 50 ug/ml Oral Solution (Dogs)
Active substance: Cabergoline
Territory / Distribution catgory: UK POM-V
Authorisation holder: Ceva Salute Animale S.p.A
Change Category: Adverse events
Summary of change:
Section 3.6: Updated: anorexia at a frequency of “very common” (more than 1 in 10 animals treated displaying adverse event(s)), vomiting at a frequency of “common”(more than 1 but less than 10 animals in 100 animals treated), and drowsiness, muscle tremor, ataxia, twitching, trembling, hyperactivity, restlessness, aggression, distress, hyperexcitation, hypotension, and allergic reaction at a frequency of “very rare” (<1 animal / 10,000 animals treated, including isolated reports).
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Librela Solution for Injection for Dogs (Range)
Active substance: Bedinvetmab
Territory / Distribution catgory: NI POM-V
Authorisation holder: Zoetis Belgium
Change Category: Adverse events
Summary of change:
Section 4.6: Updated: diarrhoea and vomiting at a frequency of “rare” (more than 1 but less than 10 animals in 10,000 animals treated) and low amounts of red blood cells (immune- mediated haemolytic anaemia), joint pain, lameness and swelling in multiple joints (immune-mediated polyarthritis), low amounts of platelets (thrombocytes) (immune-mediated thrombocytopenia), weakness, loss of movement, and convulsion at a frequency of “very rare” (<1 animal / 10,000 animals treated, including isolated reports).
SPCs available from EU Union Product Database
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Lotimax Chewable Tablets for Dogs (Range)
Active substance: Lotilaner
Territory / Distribution category: NI POM-V
Authorisation holder: Elanco GmbH
Change Category: Target species use
Summary of change:
Section 3.2: Addition of two new indications:
For the treatment of sarcoptic mange (Sarcoptes Scabiei).
By killing the vector Dermacentor reticulatus, the veterinary medicinal product reduces the risk of transmission of the vector-borne pathogen Babesia canis canis.
SPCs available from EU Union Product Database
-
Melosus 0.5 mg/ml Oral Suspension for Cats
Active substance: Meloxicam
Territory / Distribution category: NI POM-V
Authorisation holder: CP Pharma Handelsgesellschaft mbH
Change Category: Target species use
Summary of change:
Section 4.2: Addition of alleviation of pain and inflammation in acute musculo-skeletal disorders in cats.
SPC available from EU Union Product Database
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NexGard Chewable Tablets for Dogs (Range)
Active substance: Afoxolaner
Territory / Distribution category: GB POM-V
Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh
Change Category: Target species use
Summary of change:
Section 3.2 Addition of two new indications:
For reduction of the risk of infection with Babesia canis via transmission by Dermacentor reticulatus for 28 days. The effect is indirect due to the activity of the veterinary medicinal product against the vector.
For reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for 30 days. The effect is indirect due to the activity of the veterinary medicinal product against the vector.
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Nobivac L4 Suspension for Injection for Dogs
Active substance: Leptospira australis,
Leptospira canicola, Leptospira grippotyphosa, Leptospira icterohaemorrhagiae
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
Change Category: Target species use; Adverse events; Interactions and Overdose
Summary of change:
Section 3.2: Addition of new indications:
Indications against two new Leptospira serovars - Icterohaemorrhagiae and Grippotyphosa
Indications against existing Leptospira serovars Canicola, Copenhageni, Bananal/Liangguang, and Bratislava and efficacy against serovar Australis.
Section 3.6: Addition of injection site swelling up to 6.5 cm on the day of vaccination and elevated temperature ≤ 1.4 °C, up to 3 days after vaccination at a frequency of “very common” (more than 1 in 10 animals treated displaying adverse event(s)).
Section 3.8: Addition of a new associated non-mixed use claim with Nobivac Rabies.
November 2025
Change in Distribution Category from POM-V to NFA-VPS
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Beaphar WORMclear PLUS Spot-on Solution for Cats [Range]
Active substance: Emodepside, Praziquantel
Territory / Distribution category: GB & NI NFA-VPS
Authorisation holder: KRKA, d.d., Novo mesto
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Novospot Worming Solution Spot-on Solution for Cats [Range]
Active substance: Emodepside, Praziquantel
Territory / Distribution category: GB & NI NFA-VPS
Authorisation holder: KRKA, d.d., Novo mesto
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Pet Shield Worm Screen Spot-on Solution for Cats [Range]
Active substance: Emodepside, Praziquantel
Territory / Distribution category: GB & NI NFA-VPS
Authorisation holder: KRKA, d.d., Novo mesto
-
Praziquantel/Emodepside Krka Worming Spot-on Solution for Cats [Range]
Active substance: Emodepside, Praziquantel
Territory / Distribution category: GB & NI NFA-VPS
Authorisation holder: KRKA, d.d., Novo mesto
New Authorisations
-
Lyncoo 400 mg/g Powder for Use in Drinking Water for Pigs and Chickens
Active substance: Lincomycin
Territory / Distribution category: GB & NI, POM-V
Authorisation holder: Endectovet EOOD
Variations - Companion animal species
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Beaphar WORMclear PLUS Spot-on Solution for Cats [Range]
Active substance: Emodepside, Praziquantel
Territory / Distribution category: GB & NI NFA-VPS
Authorisation holder: KRKA, d.d., Novo mesto
Change Category: Target Species Use; Overdose and Interactions
Summary of change:
Section 3.2: The indication for the treatment of lungworm infections has been removed.
Section 3.8: Wording has been added recommending that veterinary advice should be sought before treatment if a cat is receiving other medications, and to inform the vet that this product is being used if other medication is provided.
Section 3.9: Additional text has been included stating that the need for, and frequency of, re-treatments should be based on professional advice and should take into account individual risk factors (the local epidemiological situation and the animal’s lifestyle).
-
Novospot Worming Solution Spot-on Solution for
Active substance: Emodepside, Praziquantel
Territory / Distribution category: GB & NI NFA-VPS
Authorisation holder: KRKA, d.d., Novo mesto
Change Category: Target Species Use; Overdose and Interactions
Summary of change:
Section 3.2: The indication for the treatment of lungworm infections has been removed.
Section 3.8: Wording has been added recommending that veterinary advice should be sought before treatment if a cat is receiving other medications, and to inform the vet that this product is being used if other medication is provided.
Section 3.9: Additional text has been included stating that the need for, and frequency of, re-treatments should be based on professional advice and should take into account individual risk factors (the local epidemiological situation and the animal’s lifestyle).
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Pet Shield Worm Screen Spot-on Solution for Cats [Range]
Active substance: Emodepside, Praziquantel
Territory / Distribution category: GB & NI NFA-VPS
Authorisation holder: KRKA, d.d., Novo mesto
Change Category: Target Species Use; Overdose and Interactions
Summary of change:
Section 3.2: The indication for the treatment of lungworm infections has been removed.
Section 3.8: Wording has been added recommending that veterinary advice should be sought before treatment if a cat is receiving other medications, and to inform the vet that this product is being used if other medication is provided.
Section 3.9: Additional text has been included stating that the need for, and frequency of, re-treatments should be based on professional advice and should take into account individual risk factors (the local epidemiological situation and the animal’s lifestyle).
-
Praziquantel/Emodepside Krka Worming Spot-on Solution for Cats [Range]
Active substance: Emodepside, Praziquantel
Territory / Distribution category: GB & NI NFA-VPS
Authorisation holder: KRKA, d.d., Novo mesto
Change Category: Target Species Use; Overdose and Interactions
Summary of change:
Section 3.2: The indication for the treatment of lungworm infections has been removed.
Section 3.8: Wording has been added recommending that veterinary advice should be sought before treatment if a cat is receiving other medications, and to inform the vet that this product is being used if other medication is provided.
Section 3.9: Additional text has been included stating that the need for, and frequency of, re-treatments should be based on professional advice and should take into account individual risk factors (the local epidemiological situation and the animal’s lifestyle).
-
CaniTrio Chewable Tablets for Dogs [Range]
Active substance: Moxidectin, Pyrantel, Sarolaner
Territory / Distribution catgory: GB POM-V
Authorisation holder: Zoetis UK Limited
Change Category: Target Species Use
Summary of change:
Section 3.2: Addition of two new indications:
- The treatment of Angiostrongylus vasorum, along with associated dosing information and precautions.
- Reduction in the risk of Dipylidium caninum via transmission by Ctenocephalides felis.
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Cazitel Plus Tablets for Dogs
Active substance: Febantel, Praziquantel, Pyrantel
Territory / Distribution catgory: NI NFA-VPS
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Change Category: Adverse events
Summary of change:
Section 3.6 of the SPC: Updated to include of adverse events: lethargy, anorexia, and hyperactivity at a frequency of very rare (<1 animal/10,000 animals treated, including isolated reports).
-
Prazitel Plus XL Tablets for Dogs
Active substance:
Febantel
Praziquantel
Pyrantel Embonate
Territory / Distribution category: NI NFA-VPS
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Change Category: Adverse events
Summary of change:
Section 3.6 of the SPC: Updated to include adverse events lethargy, anorexia and hyperactivity at a frequency of very rare (<1 animal/ 10,000 animals treated, including isolated reports).
-
YURVAC RHD Emulsion for Injection for Rabbits
Active substance: Recombinant RHDV2 virus capsid protein
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Laboratorios Hipra SA
Change Category: Adverse events
Summary of change:
Section 3.6 of the SPC: Updated to include adverse events anorexia and intestinal stasis at a frequency of very rare (<1 animal/ 10,000 animals treated, including isolated reports).
NI SPC available from the EU Union Product Database
October 2025
Change in Distribution Category from NFA-VPS to AVM-GSL
-
Drontal Plus Flavour Tablets for Dogs
Active substance: Febantel, Praziquantel,
Pyrantel Embonate
Territory / Distribution category: GB AVM-GSL
Authorisation holder: Vetoquinol UK Limited
-
Johnson’s Wormer Plus 230/20mg Film-coated Tablets for Cats & Kittens
Active substance: Praziquantel, Pyrantel Embonate
Territory / Distribution category: UK AVM-GSL
Authorisation holder: Vetoquinol UK Limited
New Authorisations
-
NeoSol 500 000 IU/g Powder for Use in Drinking Water/Milk Replacer for Cattle, Chickens, Pigs, Ducks, Turkeys, Geese, Quail and Partridges
Active substance: Neomycin sulphate
Territory / Distribution category: NI POM-V
Authorisation holder: Huvepharma NV
-
Porcilis PCV M Hyo ID Emulsion for Injection for Pigs
Active substance: Mycoplasma hyopneumoniae, Porcine circovirus-2
Territory / Distribution category: GB POM-V
Authorisation holder: MSD Animal Health UK Limited
-
Redymox 150 mg/ml Suspension for Injection for Cattle, Sheep, Pigs, Dogs and Cats
Active substance: Amoxicillin
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Univet Limited
-
Bexatil 15 mg Tablets for Cats
Active substance: Bexagliflozin
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
-
Ezi-Wormer Duo 12.5mg/125 mg Chewable Tablets for Dogs
Active substance: Milbemycin oxime (A3 and A4), Praziquantel
Territory / Distribution category: GB & NI POM-V
Authorisation holder: C&H Generics Ltd
-
Wormax Plus 12.5mg/125 mg Chewable Tablets for Dogs
Active substance: Praziquantel, Milbemycin oxime (A3 and A4)
Territory / Distribution category: GB & NI POM-V
Authorisation holder: C&H Generics Ltd
-
Wormit Plus 12.5mg/125 mg Chewable Tablets for Dogs
Active substance: Praziquantel, Milbemycin oxime (A3 and A4)
Territory / Distribution category: GB & NI POM-V
Authorisation holder: C&H Generics Ltd
Variations - food producing species
-
Anesketin 100 mg/ml Solution for Injection for Dogs, Cats and Horses
Active substance: Ketamine
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Eurovet Animal Health B.V
Change Category: Safety warnings
Summary of change:
Section 4.9 of the SPC: The vials are not vacuum-sealed and do not require air to be introduced to withdraw its content.
Introducing air into the vial prior to withdrawal of its content may lead to leakage.
-
AviPro Salmonella Vac T (Chickens)
Active substance: Salmonella typhimurium
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco Europe Ltd
Change Category: Target species use; Contraindications, Special warnings
Summary of change:
Section 3.2 of SPC: The duration of immunity for breeders and layers has been updated to 46 weeks from the time of the last vaccination.
Section 3.4: In the presence of maternally derived antibodies, a single minimum dose of vaccine administered at one day of age protects against systemic infection with Salmonella Typhimurium field strain, but no information on shedding is available. Not tested on ornamental and pure-bred poultry.
Section 3.5: The vaccine strain can also be distinguished from field strains by molecular biology methods, such as a real-time polymerase chain reaction (PCR) method.
-
Bluevac BTV Suspension for injection for cattle and sheep
Active substance: Bluetongue virus
Territory / Distribution catgory: NI POM-V
Authorisation holder: CZ Vaccines S.A.U.
Change Category: Target species use
Summary of change:
Section 3.9 of SPC: The posology for bivalent vaccines containing bluetongue virus (BTV) serotypes 1 and 4 has been updated for sheep. The following revised guidance now applies. ‘For monovalent vaccines containing bluetongue virus serotype 1 or serotype 4 administer one dose of 2 ml subcutaneously. For bivalent vaccines containing bluetongue virus serotype 1 and serotype 4 administer one dose of 2 ml subcutaneously.’
SPC available from the EU Union Product Database
-
DIVENCE IBR MARKER LIVE Lyophilisate and Solvent for Suspension for Injection (Cattle)
Active substance:
Territory / Distribution catgory: NI POM-V
Authorisation holder: Laboratorios Hipra SA
Change Category: Adverse reactions; Safety warnings
Summary of change:
Section 3.6 of the SPC: Updated to include adverse events related to a temporary mild reduction in milk production, feed intake and activity as uncommon (1 to 10 animals/10,000 animals treated).
Section 3.9 of SPC: To clarify that the vaccine should be used at a temperature between 15 °C and 25 °C prior to administration.
SPC available from the EU Union Product Database
-
Florgane 300 mg/ml Suspension for Injection for Cattle and Pigs
Active substance: Florfenicol
Territory / Distribution category: GB POM-V
Authorisation holder: Emdoka
Change Category: Contraindications and special warnings
Summary of change:
Section 5.5 of the SPC: The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.
-
Solantel 50mg/ml Oral Suspension for Sheep
Active substance: Closantel
Territory / Distribution category: NI POM-VPS
Authorisation holder: Norbrook Laboratories Limited
Change Category: Withdrawal period
Summary of change:
Section 4.11 of the SPC: Withdrawal period for meat and offal 56 days.
Variations - Companion animal species
-
Anesketin 100 mg/ml Solution for Injection for Dogs, Cats and Horses
Active substance: Closantel
Territory / Distribution category: GB & NI POM-V
Authorisation holder: Eurovet Animal Health B.V
Change Category: Safety warnings
Summary of change:
Section 4.9 of the SPC: The vials are not vacuum-sealed and do not require air to be introduced to withdraw its content.
Introducing air into the vial prior to withdrawal of its content may lead to leakage.
-
Bravecto TriUNUM Chewable Tablets for Dogs (Range)
Active substance: Fluralaner, Moxidectin, Pyrantel
Territory / Distribution category: NI POM-V
Authorisation holder: Intervet International B.V.
Change Category: Target species use
Summary of change:
Addition of treatment claim for Angiostrongylus vasorum (the causative agent of angiostrongylosis).
SPCs available from EU Union Product Database
-
Cazitel Plus XL Tablets for Dogs
Active substance: Febantel, Praziquantel, Pyrantel Embonate
Territory / Distribution category: NI NFA-VPS
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Change Category: Adverse reactions
Summary of change:
Section 4.6 of the SPC: Updated to include adverse events lethargy, anorexia and hyperactivity at a frequency of very rare (<1 animal/ 10,000 animals treated, including isolated reports).
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Dronspot 30 mg/7.5 mg Spot-on Solution for Small Cats; Dronspot 60 mg/15 mg Spot-on Solution for Medium Cats; Dronspot 96 mg/24 mg Spot-on Solution for Large Cats
Active substance: Emodepside, Praziquantel
Territory / Distribution category: GB NFA-VPS
Authorisation holder: Vetoquinol UK Limited
Change Category: Name change
Summary of change:
The name change to 'Drontal wormer'
-
Drontal Plus Flavour Tablets for Dogs
Active substance: Febantel, Praziquantel,
Pyrantel Embonate
Territory / Distribution category: GB AVM-GSL
Authorisation holder: Vetoquinol UK Limited
Change Category:
Summary of change:
Name change to 'Johnson’s Wormer Plus 150/144/50 mg Tablets for Dogs & Puppies'
-
Eluracat 20 mg/ml Oral Solution for Cats
Active substance: Capromorelin tartrate
Territory / Distribution category: GB POM-V
Authorisation holder: Elanco GmbH
Change Category: Adverse reactions
Summary of change:
Section 3.6 of the SPC: Updated to include adverse events anorexia and behavioural disorder (rare frequency) and loss of consciousness, sedation, recumbency and dyspnoea (very rare frequency).
-
Prazitel Plus Tablets for Dogs
Active substance: Febantel, Praziquantel, Pyrantel
Territory / Distribution category NI NFA-VPS
Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Change Category: Adverse reactions
Summary of change:
Section 3.6 of the SPC: Updated to include lethargy, anorexia and hyperactivity as very rare (<1 animal /10,000 animals treated, including isolated reports).
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